NCT05763524

Brief Summary

This project will evaluate of the number of patients who underwent adrenalectomy for ACC in different European centers using the EUROCRINE® database. The analysis will focus on the extent of lymph nodal dissection (i.e. number of lymph nodes and nodal stations dissected during adrenalectomy). We aim to evaluate the oncologic radicality of surgical treatment and the rate of tumour recurrences after surgery and nodal metastasis related to the stage of the disease and to tumour side (left/right).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 20, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 28, 2023

Last Update Submit

March 16, 2023

Conditions

Keywords

Adrenocortical CarcinomaLymphadenectomyEurocrine

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adrenocortical Carcinoma (ACC) among European endocrine centers

    Identification of the number of patients who underwent adrenalectomy for diagnosis of ACC among European centers participating in the Eurocrine database

    January 2015- January 2021

  • Extent of lymphadenectomy

    Evaluation of the lymph node dissection extension (in terms of number of lymph nodes and nodal stations dissected during surgical treatment for ACC)

    January 2015- January 2021

Secondary Outcomes (1)

  • Oncologic outcomes

    January 2015- January 2021

Study Arms (1)

Adrenalectomy in patients operated for Adrenocortical Carcinoma

All adult (18 years old and older) patients registered in EUROCRINE® database that underwent surgery for adrenocortical carcinoma from 2015 till 2021 will be included

Procedure: Adrenalectomy with or without lymphadenectomy

Interventions

Regarding lymphadenectomy extent, it will be described as locoregional or systematic depending on availability of data in the Eurocrine database.

Adrenalectomy in patients operated for Adrenocortical Carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with final histology of adrenocortical carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021

You may qualify if:

  • All adult (18 years old and older) patients
  • underwent surgery
  • final histology of adrenocortical carcinoma
  • among European centers that participate in the Eurocrine® database between 2015 and 2021

You may not qualify if:

  • Patients \<18 years old
  • Patients with metastatic disease at time of clinical referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

AdrenalectomyLymph Node Excision

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Raffaelli, Prof

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 10, 2023

Study Start

December 15, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

March 20, 2023

Record last verified: 2023-02

Locations